Somatrogon, sold under the brand name Ngenla, is a

medication A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field an ...

for the

treatment Treatment may refer to: * "Treatment" (song), a 2012 song by * Film treatment, a prose telling of a story intended to be turned into a screenplay * Medical treatment or therapy * Sewage treatment * Surface treatment or surface finishing * Water ...

growth hormone deficiency Growth hormone deficiency (GHD), or human growth hormone deficiency, is a medical condition resulting from not enough growth hormone (GH). Generally the most noticeable symptom is that an individual attains a short height. Newborns may also prese ...

. Somatrogon is a glycosylated

protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, respon ...

constructed from

human growth hormone Growth hormone (GH) or somatotropin, also known as human growth hormone (hGH or HGH) in its human form, is a peptide hormone that stimulates growth, cell reproduction, and cell regeneration in humans and other animals. It is thus important in ...

and a small part of

human chorionic gonadotropin Human chorionic gonadotropin (hCG) is a hormone for the maternal recognition of pregnancy produced by trophoblast cells that are surrounding a growing embryo (syncytiotrophoblast initially), which eventually forms the placenta after implantati ...

which is appended to both the

N-terminal The N-terminus (also known as the amino-terminus, NH2-terminus, N-terminal end or amine-terminus) is the start of a protein or polypeptide, referring to the free amine group (-NH2) located at the end of a polypeptide. Within a peptide, the amin ...

and

C-terminal The C-terminus (also known as the carboxyl-terminus, carboxy-terminus, C-terminal tail, C-terminal end, or COOH-terminus) is the end of an amino acid chain (protein or polypeptide), terminated by a free carboxyl group (-COOH). When the protein is ...

. Somatrogon is a human growth hormone analog. The most common side effects include reactions at the site of injection, headache, and fever. Somatrogon was approved for medical use in Australia in November 2021, in the European Union in February 2022, and in the United States in June 2023.

Medical uses

Somatrogon is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone.

History

The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA) approved somatrogon based on one clinical trial (NCT02968004) of 224 children with growth hormone deficiency and short stature. The trial was conducted at 84 sites in 24 countries including Argentina, Australia, Bulgaria, Belarus, Canada, Colombia, Germany, Georgia, Greece, India, Israel, Italy, Mexico, New Zealand, Poland, South Korea, Russia, Spain, Taiwan, Turkey, Ukraine, the United Kingdom, Vietnam, and the United States. This trial was used to assess efficacy and safety. The benefits and side effects were evaluated in a clinical trial. Children aged 3 to 12 years old were assigned at random to weekly somatrogon or another daily approved growth hormone for 52 weeks.

Society and culture

Legal status

In December 2021, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee A committee or commission is a body of one or more persons subordin ...

of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ngenla, intended for the treatment of

in children and adolescents from three years of age. The applicant for this medicinal product is Pfizer Europe MA EEIG. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Somatrogon was approved for medical use in the European Union in February 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

Names

Somatrogon is the international nonproprietary name.

Medical uses

History

Society and culture

Legal status

Names

References

Further reading